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Breast CancerPhase 1NCT01937689

Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer

A Phase 1 study testing Pyrotinib in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2 positive advanced breast cancer: To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Breast Cancer
What is being tested?
Pyrotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Jan 2013to Dec 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 and ≤70 years.
  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • At least one measurable lesion exists.(RECIST 1.1)
  • Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
  • Required laboratory values including following parameters:
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  • ANC: ≥ 1.5 x 109/L
  • Platelet count: ≥ 100 x 109/L
  • Hemoglobin: ≥ 9.0 g/dL
  • Total bilirubin: ≤ 1.5 x upper limit of normal, ULN
  • ALT and AST: ≤ 1.5 x ULN
  • BUN and creatine clearance rate: ≥ 50 mL/min
  • LVEF: ≥ 50%
  • QTcF: < 470 ms
  • Signed informed consent.

Who cannot join

  • Subjects with third space fluid that can not be controled by drainage or other methods.
  • Steroid treatment for more than 50 days, or in need of long-term use of steroids.
  • Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  • Less than 4 weeks from the last radiotherapy,chemotherapy，surgery，hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
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  • Subjects with intracranial lesions.
  • Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) before study entry.
  • Receiving any other antitumor therapy.
  • Less than 4 weeks from the last clinical trial.
  • Known history of hypersensitivity to pyrotinib or any of it components.
  • Ongoing infection (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
  • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  • Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period.
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to,hypertension, severe diabetes, or thyroid disease.
  • Alcoholism, smoking (daily ≥ 5 roots) and other bad habits.
  • Known history of neurological or psychiatric disease, including epilepsy or dementia.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase I Study of Pyrotinib in Patients With HER2 Positive Advanced Breast Cancer

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2 positive advanced breast cancer:

  • To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD)
  • To determine the dose-limiting toxicity (DLT)
  • To determine the pharmacokinetic profile of Pyrotinib and its metabolites
  • To assess preliminary antitumor activity
  • To determine preliminary regimen dose for phase II study
  • To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
Conditions
Breast Cancer
Being tested
Pyrotinib
Keywords
Breast cancer, advanced, Pyrotinib, Phase I, HER2 positive advanced breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PyrotinibDrug

    Pyrotinib either at 80, 160, 240, 320, 400, 480 mg ....., p.o. once daily.

Study groups in NCT01937689
Study groupRoleWhat they receive
PyrotinibExperimentalEach subject will receive a single dose of pyrotinib on day 1, followed by 4-day observation period, and then subject will receive pyrotinib once daily for 28 days during cycle 1.Each cycle will consists of 28 days.
Receives: Drug: Pyrotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.

    Measured: 4 weeks

Secondary outcomes (6)

  1. Number of participants with adverse events.

    Measured: 8 weeks

  2. Objective response rate (ORR).

    Measured: 8 weeks

  3. Pyrotinib pharmacokinetic parameter: Cmax.

    Measured: 4 weeks

  4. Pyrotinib pharmacokinetic parameter: Tmax.

    Measured: 4 weeks

  5. Pyrotinib pharmacokinetic parameter: t1/2.

    Measured: 4 weeks

  6. Pyrotinib pharmacokinetic parameter: AUC.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJul 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937689
Sponsor's protocol ID
BLTN-Ib
Status last verified
Jul 2018
First submitted
14 Aug 2013
Last updated
9 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Guan X, Ma F, Li Q, Chen S, Lan B, Fan Y, Wang J, Luo Y, Cai R, Zhang P, Li Q, Xu B. Survival benefit and biomarker analysis of pyrotinib or pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer: a pooled analysis of two phase I studies. Biomark Res. 2023 Feb 20;11(1):21. doi: 10.1186/s40364-023-00453-0.

    PubMed 36803645

  • Ma F, Zhu W, Guan Y, Yang L, Xia X, Chen S, Li Q, Guan X, Yi Z, Qian H, Yi X, Xu B. ctDNA dynamics: a novel indicator to track resistance in metastatic breast cancer treated with anti-HER2 therapy. Oncotarget. 2016 Oct 4;7(40):66020-66031. doi: 10.18632/oncotarget.11791.

    PubMed 27602761

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pyrotinib in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937689, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.

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